ATTACHMENT 7.pdf

ATTACHMENT 7: ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS

FORMAT FOR TECHNICAL PROPOSAL, and TABLE OF CONTENTS

DEVELOPMENT OF RADIOLOGICAL/NUCLEAR MEDICAL COUNTERMEASURES

(MCMS) AND BIODOSIMETRY DEVICES

BAA 75N93026R00004

It is strongly recommended that offerors use the following template as the format for the Technical Proposal. All information presented in the Technical Proposal should be presented in the order specified below.

These Additional Technical Proposal Instructions reflect the requirements of the BAA and provide specific instructions and formatting for the Technical Proposal. While Section L. of the BAA provides a generic set of Technical Proposal Instructions applicable to all NIH R&D solicitations, these Additional Technical Proposal Instructions are tailored to the specific requirements of the BAA. The information requested in these instructions should be used along with Section L of the BAA to format and prepare the

Technical Proposal and should be used as a Table of Contents for your Technical Proposal. Offerors should follow the instructions in Section L of the BAA, and include the information requested here.

Offerors are advised to give careful consideration to the Broad Agency Announcement Description, Background and Introduction, Research and Technical Objectives, all reference materials and attachments, the Technical Evaluation Criteria in Section M, and the BAA as a whole in the development of their Technical Proposals.

Offerors proposing subcontracts and/or consultants to perform portions of the proposed Statement of Work should clearly identify the specific tasks for which they plan to utilize subcontractors and/or consultants, as well as the method and level of integration/coordination between the prime Contractor and all proposed subcontractors and/or consultants, and the expected advantages of such an approach.

Offerors must refer to the BAA Attachment entitled “Packaging and Delivery of the Proposal,” which details strict guidelines, including page limitations, formatting and layout of proposals, and prohibits the offerors use of links to internet web site addresses (URLs) to direct readers to alternate sources of information.

TECHNICAL PROPOSAL – TABLE OF CONTENTS

SECTION 1:

1) PROPOSAL TITLE PAGE. Include BAA title and number, name of organization, UEI number and identify if the proposal is an original or a copy. Offerors that include data in their proposals that they do not want disclosed to the public for any purpose, or used by the Government except for evaluation purposes, shall also include the legend regarding

Restriction on Disclosure and Use of Data prescribed by FAR 52.215-1 (e)]

2) TABLE OF CONTENTS

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https://www.acquisition.gov/far/part-52#FAR_52_215_1

SECTION 2: TECHNICAL PROPOSAL OVERVIEW (suggested 3-page maximum)

Provide a brief description of the proposed project, including:

1. 1-2 sentence summary describing the concept the offeror is proposing.

2. A summary describing the scope of the activities proposed.

3. A brief description of the activities proposed by the offeror and all proposed subcontractors, including identification of all proposed subcontractors and a list of key personnel for the offeror and the proposed subcontractors with degrees, titles, and role in the project.

4. By area of expertise, provide the total number of staff, the number available to be assigned to the contract for the offeror and all proposed subcontractors, and total number of additional staff to be hired and trained.

5. A brief description of the facilities and other resources to be made available by the proposed prime contractor (offeror) and any proposed subcontractors.

SECTION 3: STATEMENT OF WORK FORMAT (suggested maximum of 5 pages)

Offeror(s) are required to provide a Statement of Work in their proposal. The Statement of Work shall be developed by each offeror based on the information in the Attachment entitled “Research and Technical Objectives,” and shall consist of two parts: (1) Scope, and

(2) Technical Requirements. Provided below is an outline of the Statement of Work format that should be used by all offeror(s) in the preparation of their Technical Proposals. The headers and sub-headers may be adjusted to match the requirements as proposed in each offeror’s individual technical proposal.

Contracts awarded as a result of this BAA will include the Statement of Work proposed by the offeror, as negotiated and accepted by the Government. Offeror(s) will be required to perform the activities and provide the resources appropriate to the scope of their specific negotiated Statement of Work.

The opening paragraph under the Technical Requirements section of the Statement of Work shall be followed by a description of all activities that the Contractor shall perform after the award of the contract. The Technical Requirements shall include all activities required to effectively implement the project and shall include a description of all items to be delivered to the Government during performance of the contract, such as progress reports, financial reports, end products, and other deliverables, along with a timetable for their delivery.

[NOTE TO OFFEROR: Each offeror shall provide detailed specifications of the requirement utilizing the following sample outline of tasks and subtasks. Any tasks or subtasks that are not applicable to your proposed effort should be deleted. Any tasks or subtasks specific to your proposed effort not addressed below shall be added.]

[See Statement of Work outline on next page]

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SAMPLE STATEMENT OF WORK

1. SCOPE

Instruction to offerors: Provide a brief description (one to two paragraphs) of the overall project and objectives in broad terms that indicates the size and magnitude of the proposed effort.

2. TECHNICAL REQUIREMENTS

[NOTE TO OFFEROR: The Technical Requirements shall begin with the following introductory paragraph.]

Independently, and not as an agent of the Government, the Contractor shall furnish all necessary services, qualified professional, technical, and administrative personnel, material, equipment and facilities, not otherwise provided by the Government under the terms of this contract, as needed to perform the tasks set forth below. Specifically, the Contractor shall:

A. Product Development Plan

1. Research and Development

a. Efficacy/validation Studies (including model and assay development)

b. Animal and/or NAMs Studies (including pharmacology/toxicology or biokinetics of biodosimetry signature)

2. Manufacturing and CMC Development

3. FDA IND- or IUO-enabling studies/activities

B. Regulatory Compliance, Quality Control, Assurance, and Data

Management

C. Communication and Contract Review Meetings

SECTION 4: TECHNICAL DISCUSSIONS

In addition to the guidance in section l of the BAA, this section of your technical proposal should include documentation to demonstrate how you will accomplish the work detailed in your proposed Statement of Work. It is recommended that your proposal be organized in accordance with the order of your Statement of Work and the technical evaluation criteria provided in Section M.

Additionally, please ensure that your Technical Proposal addresses the following:

A. Product Development Plan:

The National Institute of Allergy and Infectious Diseases (NIAID) recognizes that the regulatory path to licensure for products within the scope of this BAA may not have been previously defined. Regulatory requirements are likely to be defined in an iterative process

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with the United States (U.S.) Food and Drug Administration (FDA) based on product-specific data as it emerges.

Provide a Product Development Plan that details the specific tasks and stages that the

Offeror proposes to perform that can reasonably be completed in three years. When providing details for the Product Development Plan outlined in the SOW, include the following:

a. A description of how the lead medical countermeasures (MCM) candidate or biodosimetry signature/device meets the technical requirements outlined in the Research and Technical Objectives section.

b. The lead MCM must have a defined Target Product Profile.

c. The lead biodosimetry signature and/or device must have a defined Target Product

Profile.

d. Documentation that the Offeror has intellectual property (IP) protection and/or proprietary freedom to use all components to develop the proposed MCM candidate or biodosimetry signature/device, including being a sponsor for submission to the U.S.

FDA for clearance, licensure, or approval, and commercialization. Include letters from any IP-holders stating that they will provide the agent(s) or technical component(s) for the duration of the project, any limitations on the studies to be performed with that agent(s), agreement about public disclosure of results (including negative results), and whether there are any agreements in place already.

e. Details of the critical path to licensure for the proposed product, based on current data and/or discussions with the U.S. FDA. Specify the elements of this critical path that would be completed under this contract. Describe any prior FDA communications about the lead MCM candidate and/or biodosimetry signature/device (This information should not exceed 1 page).

f. Activities and stages of product development that the Offeror proposes to perform under contract funding, including Go/No Go decisions for advancement to the next stage.

g. Milestones (quantifiable with accompanying timelines) for initiation, conduct and completion of product development activities for each stage, analysis of outcomes and findings, and preparation of detailed reports summarizing results of work completed and an analysis of data as it relates to qualitative and quantitative criteria established for Go/No Go decision making. Provide a Gantt chart or alternatives (Kanban board, Scrum board) of proposed activities.

h. Contract recipients will be expected to participate in a NIAID-sponsored, program-wide dosimetry harmonization effort to ensure accurate radiation exposures. Contractors will participate by communicating with the NIAID-identified dosimetry contractor about specifics of radiation exposures employed in the contract and will be provided with tools to verify dosimetry measurements.

i. A detailed discussion of the proposed technical approach for each activity to be performed to achieve the project objectives, containing sufficient detail to fully explain and justify the scientific and technical rationale for the proposed approach and methodologies. When applicable, also include: (i) detailed information on radiation

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dosimetry and irradiator set-up (e.g., radiation dose and quality, dose rate, source, geometry of irradiation); (ii) plans to ensure the correct dose is delivered (e.g., frequency of dosimetry calibration, in-run dosimetry, if appropriate). Radiation exposure type, dose level, and dose rates proposed for the study must be relevant to a terrorist incident or accidental exposure.

j. An analysis of risks that could compromise performance of activities described in the Statement of Work, along with a risk mitigation plan in the event that the specified risks materialize.

k. The National Institutes of Health (NIH) expects that sex as a biological variable (SABV) will be factored into research designs, analyses, and reporting in vertebrate animals, human new approach methodologies (NAMs), and/or human studies. Strong justification from the scientific literature, preliminary data, or other relevant considerations must be provided for applications proposing to study only one sex.

Further information regarding NIH expectations for the consideration of SABV is provided here: NOT-OD-15-102.

l. Inclusion of populations vulnerable to radiation exposure (e.g., pediatric and geriatric) in the research plan, including the development of appropriate animal models or NAMs to test the biokinetics of the biodosimetry signature or efficacy of the lead MCM, if applicable.

B. Regulatory Compliance, Quality Control, Assurance, and Data

Management

Describe the organization’s programs to manage data, assure data quality, and comply with the requirements of regulatory agencies.

a. Include a description of: (1) the proposed data management process that will be used for all studies; (2) the procedures for data entry and validation; (3) documentation of data corrections, routine maintenance and backup, transmission of data, data reporting and exporting system, access control and confidentiality, and data retrieval and disaster recovery; and (4) statistical design and analysis resources that will be used to support contract activities.

b. Describe procedures to be used to maintain documentation adhering to U.S. FDA regulatory standards and published guidance documents, for the conduct of assays under Good Laboratory Practice (GLP) and manufacturing under Current Good Manufacturing Process (cGMP) standards. Include information on data management for GLP and cGMP activities (as appropriate to the Statement of

Work).

c. Describe processes and procedures for regulatory compliance, including timing of audits, timely scheduling of audits, performance of audits, responding to audit reports and supporting documentation, as well as an audit history of the facilities proposed for use in carrying out contract activities (as appropriate to the

Statement of Work).

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ATTACHMENT 7

https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-102.html

C. Communication and Contract Review Meetings

Document how the Offeror will ensure compliance with the post-award activities described below:

a. Collaborations:

Contractors shall collaborate with other contractors awarded through this solicitation, including sharing of novel research reagents and other resources.

b. Contract Initiation and Annual Review Meetings:

Contractors are required to attend a contract initiation meeting within 90 days of the effective award date at Rockville, MD, and annual review meetings thereafter (either in MD or a site mutually agreed upon between NIAID/ Radiation and

Nuclear Countermeasures Program [RNCP] and the Offeror).

Initiation Meeting: The purpose of the contract initiation meeting is to introduce the projects, facilitate scientific discussion, and establish working relationships.

Annual Meetings: The Contracting Officer’s Representative (COR) will plan, conduct, and be responsible for logistical arrangements for an annual review meeting to be held. Contractor Principal Investigators (PIs), Project Managers, key personnel (including subcontractor personnel), the COR, and other designated NIH staff shall attend these meetings. The COR may invite other

Government staff to attend these meetings.

Contractors shall provide:

• Updates on results of activities undertaken or completed since the last review meeting

• Updates on the predicted milestones, including an updated Gantt chart

• A description of any problems encountered or anticipated and approaches to overcoming them

• A description of activities to be undertaken in the coming year

• The Contractor shall provide a copy of any slide presentations to the COR no later than 3 days after the annual meeting.

c. Site Visits:

The Contracting Officer or COR may conduct site visits at the Contractor site(s) annually with advance notice. The Contractor shall plan, conduct and be responsible for the logistical arrangements for site visit meetings at the Contractor’s facility. The PI, Project Manager, key contractor and subcontractor personnel, the COR, and other designated NIH staff, shall attend the meetings, unless directed otherwise by the Contracting Officer or the COR. The Contractor shall provide a copy of any slide presentations to the COR no later than 3 days after the meeting.

d. Teleconferences:

The Contractor shall plan and conduct monthly teleconference meetings with the COR, and other designated NIH staff, during the contract period of performance, to discuss technical progress and financial invoices. Three days prior to the teleconference, the Contractor shall submit an electronic copy of the agenda to the COR. Within one week after the teleconference, the Contractor shall provide an electronic copy of a meeting summary of the teleconference to the COR. The

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timing or agenda of the teleconference meetings may be altered or adjusted by the COR as needed to address progress on the contract.

e. Additional Contract Meetings/Teleconferences:

The PI, Project Manager, key contractor, and subcontractor personnel shall attend additional meetings or teleconferences at the request of the Contracting Officer or the COR. Such meetings will be requested, as necessary, to discuss contract-specific issues and to review recommended changes or deviations from milestones and timelines in the Statement of Work.

f. Meetings with the FDA:

The Contractor shall share any FDA communications involving the NIAID award with the COR and NIAID within 10 days of receipt. The Contractor shall forward the dates and times of any meetings with the FDA regarding activities supported by the contract to the Contracting Officer and COR and arrange for NIH staff to attend. The Contractor shall provide the COR with documentation supplied to the

FDA at least 3 days in advance of these meetings, and the final draft minutes of any meeting with the FDA should be provided to NIAID within 10 days.

g. Audit Reports:

Within thirty calendar days of completion of an audit related to conformance to

FDA regulations and guidance, including adherence to GLP, cGMP, or Good Clinical Practice (GCP) guidelines, the Contractor shall provide the COR with copies of the audit report and a plan for addressing areas of nonconformance to

FDA regulations and guidance for GLP, cGMP, or GCP guidelines as identified in the final audit report.

Organizational Experience:

In addition to the information requested under Section L, Part c. Business Proposal Instructions, paragraph 12, Qualifications of the Offeror, all offerors are requested to include in their technical proposals a description of at least two examples of similar projects performed by your organization that are of comparable size and scope and/or related to the effort proposed in response to this BAA. The projects may be either completed or ongoing.

SECTION 5: SCIENTIFIC AND TECHNICAL PERSONNEL

Provide information relevant to document individual training, experience, qualifications, and expertise necessary for the successful completion of the proposed Statement of Work. Limit CVs to 2-3 pages and provide selected references for publications relevant to the scope of the contract.

1) Principal Investigator (PI): Describe the experience, training, expertise, and qualifications, and level of effort of the proposed Principal Investigator to lead and direct the activities to be carried out under the proposed Statement of Work. Document the experience of the PI with performing studies of comparable size and scope (completed or

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ongoing) in accordance with FDA regulations and published guidance documents, as appropriate to the proposed Statement of Work.

2) Other Key Scientific and Technical Personnel: Describe the experience, training, expertise, and qualifications, as well as the level of effort, for all proposed key scientific and technical personnel. Address scientific and technical expertise in radiation biology, radiation dosimetry/health physics, statistics, or product development. Include the qualifications and/or certifications of the staff that will oversee radiation dosimetry and irradiator set-up.

SECTION 6: PROJECT MANAGEMENT

1) Provide a Project Management Plan for the overall organization that addresses the planning, initiation, implementation, conduct, monitoring and completion of tasks identified in the proposed Statement of Work. If consultants and/or subcontractors are proposed, include a plan to manage, coordinate, and oversee the work performed by consultants and/or subcontractor(s).

2) Provide a Staffing Plan that describes roles, responsibilities, and level of effort for all scientific and technical personnel, including all proposed subcontractors and consultants.

Provide an administrative and technical framework indicating clear lines of authority and responsibility for all proposed personnel. Describe processes for replacement, projections of future staffing needs, and talent acquisition. Include a chart of the proposed organizational/management structure for the project.

3) Describe the project management systems that will be used to track activities and to keep multiple activities on time and on budget. The plan must include a description of the quality control methods that will be used to ensure effective and efficient initiation, implementation, management, and oversight of contract requirements.

4) Outline how the PI (or Project Manager) will communicate with the Contracting Officer’s Representative and Contracting Officer and how the PI (or Project Manager) will communicate, monitor, and manage the project both internally and externally (at subcontractor facilities).

SECTION 7: FACILITIES, EQUIPMENT, AND OTHER RESOURCES

The Technical Proposal should document availability and adequacy of facilities, equipment, space, and other resources necessary to carry out the proposed Statement of Work, including:

1) Location and features of facilities, including a floor plan and a list of equipment and resources dedicated to the project for the prime contractor and any proposed subcontractors (lease or ownership information should be provided).

2) Provide procedures to be utilized to ensure compliance with all safety guidelines and regulations, including training and monitoring of personnel.

3) Describe facility security, including computer and information security. Document entry access to facilities of the contractor or subcontractor(s), if any, for performing assays and animal studies under GLP standards and production of therapeutic material under cGMP guidelines.

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4) Describe provisions for complying with Public Health Service and Department of Agriculture guidelines and regulations for the housing and humane care and use of laboratory animals as prescribed by the Office of Laboratory Animal Welfare (OLAW) the

USDA Animal Welfare Act and the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC), as applicable.

5) Identification and description of ALL support resources (including Information Technology systems) that will be required to effectively complete the proposed

Statement of Work.

6) Describe provisions for ensuring safe facilities for the conduct of work and the controls and provisions to be in place for handling radioactive materials and irradiation equipment.

SECTION 8: OTHER CONSIDERATIONS

Other than those detailed in the Government Furnished Property clause or otherwise publicly available, the offeror shall not propose government furnished resources, to include government employees, facilities, intellectual property, or biological materials. If you propose government-furnished resources, your proposal will not be considered further for award.

This section of the Technical Proposal should document other resources not covered in Section

7, 1 through 4 above, that are necessary to carry out the proposed Statement of Work.

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ATTACHMENT 7

https://olaw.nih.gov/ https://www.nal.usda.gov/animal-health-and-welfare/animal-welfare-act https://www.aaalac.org/ https://www.aaalac.org/